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Stability Programme Co-Ordinator (Quality Assurance) - 2 year Secondment / Fixed

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United Kingdom  United Kingdom
Supply Chain/Logistics, English
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Job Description:

We are currently looking to recruit for a Stability Programme Co-Ordinator to work within the (COMPANY NAME) Worthing sites' Quality Assurance function.

Job Purpose:
As Stability Coordinator, you will drive the process, ensuring procedures meet requirements, while assisting in the identifications of batches for testing, including the need for stability testing following change control or process deviations.

You will manage storage, labelling and overall stability management of product in chambers, providing an efficient and accurate sample and stability chamber management service to penicillin producing sites within the (COMPANY NAME) network according to ICH, regulatory and capacity requirements.

You will oversee the planning and strategic management of Stability trials and Stability testing in conjunction with the Value Streams and laboratories at (COMPANY NAME) Worthing (UK) and at (COMPANY NAME) Mayenne (France), reporting results in a timely and accurate manner and overseeing the Annual Review process.

Key Responsibilities (include):
* Responsible for requesting, receipt and delivery of stability samples. Accountable for the design of Stability Protocols, influencing content and processes and exerting advocacy for regulatory and QMS requirements whilst maximising the business benefit and scientific understanding generated from the stability protocol design. Responsible for set up and management of stability studies in electronic (LIMS) systems, including troubleshooting as required.
* Own the process for preparation, labelling and storage of stability samples within temperature and humidity controlled environmental chambers in accordance with approved protocols and procedures. Maintain a Database of samples, pull dates and storage conditions following written procedures and protocols. Manage the capacity for stability sample storage, reliably predict shortfalls, suggest and implement appropriate solutions.
* Provide first line response to alarms for deviations from set environmental conditions in a timely fashion to reduce adverse effect on the quality control of products. Record and identify actions to address deviations from set temperature and humidity conditions of stability chambers.
* Approve and report data generated by the laboratories at (COMPANY NAME) Worthing. Contribute to the review of laboratory OOS/ OOT investigations and deviations to identify trends and preventative actions.
* Manage the Stability Annual Review (SAR) process, delegating authorship as required and ensuring that the programme aligns with the site PPR schedule. Utilise data to provide information and knowledge to support the regulatory dossier. Contribute to Quality Incident investigations.
* Lead the preparation for Level 2 to 4 inspections involving Stability.
* Responsible for all processes and SOPs used for stability testing from sample receipt and storage through to data reporting.
* Provides advice and support to the site on stability regulations, maintains current knowledge of best practice and awareness of ICH requirements for stability testing.
* Liaise with manufacturing to include activities such as the tracking and issue resolution of specific transfer projects, optimization of the process with reduced costs and improved quality and speed, seeking procurement leverage of outsourced activities.
* Responsible for the knowledge management activities between sites. Ensure this remains a value added and robust process by working with corresponding roles to track, capture, and implement improvements to study plans and processes.

Please Note: This is a Fixed Term Contract opportunity (currently circa 2-year in duration).

About You:
This role would suit a motivated individual who has experience in a Quality and/or Laboratory role, ideally with some knowledge/experience of working within a complex GMP environment. The individual should be a self-starter with keen attention to detail and compliance at the forefront of their decision-making process. A strong quality and continuous improvement mind-set, as well as strong communication skills are also needed.

About Worthing Manufacturing Site:
Manufacturing at the Worthing site is for antibiotics. It is advised that you take this into consideration when deciding to apply for this position.

APPLICATION CLOSING DATE - Monday 31st of January 2022 (COB)

When applying for this role, please use your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you provide in your CV will be used to assess your application.

About (COMPANY NAME):
(COMPANY NAME) is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on (COMPANY NAME) please refer to our website: wxx.xxx.xxm

Basic Qualifications:
* Degree level qualification (or strong equivalent experience) in an appropriate scientific, technical or engineering discipline.
* Relevant experience in a Quality / Laboratory role within the pharmaceutical, medical device or consumer healthcare industry.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at (COMPANY NAME) bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0xxx xxx xxx1, or send an email uxxxxxxxxxx.xxxxxxxxxxx@xxx.xxm

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Important notice to Employment businesses/ Agencies

(COMPANY NAME) does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact (COMPANY NAME)'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to (COMPANY NAME). The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and (COMPANY NAME). In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of (COMPANY NAME). (COMPANY NAME) shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements. For more information, please visit (COMPANY NAME)'s Transparency Reporting For the Record site

Source: Company website
Posted on: 15 Jan 2022
Industry: Health Care
Languages: English
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